Methods, systems and devices for pre-operatively planned shoulder surgery guides and implants

ABSTRACT

Methods, systems and devices for pre-operatively planned shoulder surgery guides and implants. Pre-operative planning methods for designing a shoulder surgery guide based on considerations of multiple factors affecting the outcome of shoulder surgery. Methods of using surgery guides and implants in patients undergoing shoulder surgery.

CROSS REFERENCE TO RELATED APPLICATION

This application claims the benefit of U.S. Provisional PatentApplication Ser. No. 61/889,213, filed Oct. 10, 2013, the disclosure ofwhich is incorporated herein by reference in its entirety.

TECHNICAL FIELD

The presently disclosed subject matter relates to methods, systems anddevices for pre-operatively planned shoulder surgery guides andimplants. The presently disclosed subject matter also relates to the useof such surgery guides and implants in patients undergoing shouldersurgery.

BACKGROUND

Shoulder replacement is a common surgical operation that has achievedpositive results for many patients. Indeed, approximately 10% of jointreplacement procedures globally are related to the shoulder. Manyshoulder procedures are performed in a patient where substantiallynormally bone exists for orientation and fixation of a prostheticreplacement, or resurfacing. In these cases, the need for the shoulderreplacement can often times be related mostly to the arthritic conditionof the joint, and relative absence of healthy cartilage.

In some patients, however, one or more of the bones of the shoulder arenot only arthritic, but have also had previous conditions that havecaused bone to wear away. In such cases, there may not be sufficientbone to adequately affix a prosthetic implant to the bone, or the bonesmay have been worn such that the orientation of a joint replacementcannot be satisfactorily determined to ensure a positive patientoutcome.

There are a number of factors that complicate the selection, orientationand affixation of prosthetic implant devices, such as glenoid implantsand/or humeral implants. Failure to properly account for each factor canlead to improperly sized, misaligned and/or poorly affixed implants thatresult in a poor surgical outcome for the patient.

In order to increase the likelihood of successful patient outcomes inpatients undergoing shoulder surgery, methods, systems and devices areneeded that allow for the full understanding and incorporation of allnecessary factors for optimization of shoulder implant selection andplacement. Thus, a need remains for methods, systems and devices forpre-operatively planned shoulder surgery guides and implants thatachieve desired outcomes.

SUMMARY

The presently disclosed subject matter provides methods, systems anddevices for pre-operatively planned shoulder surgery guides andimplants. The presently disclosed subject matter also provides uses ofsuch surgery guides and implants in patients undergoing shouldersurgery.

An object of the presently disclosed subject matter having been statedhereinabove, and which is achieved in whole or in part by the presentlydisclosed subject matter, other objects will become evident as thedescription proceeds when taken in connection with the accompanyingExamples as best described hereinbelow.

BRIEF DESCRIPTION OF THE DRAWINGS

The presently disclosed subject matter can be better understood byreferring to the following figures. The components in the figures arenot necessarily to scale, emphasis instead being placed uponillustrating the principles of the presently disclosed subject matter(often schematically). In the figures, like reference numerals designatecorresponding parts throughout the different views. A furtherunderstanding of the presently disclosed subject matter can be obtainedby reference to an embodiment set forth in the illustrations of theaccompanying drawings. Although the illustrated embodiment is merelyexemplary of systems for carrying out the presently disclosed subjectmatter, both the organization and method of operation of the presentlydisclosed subject matter, in general, together with further objectivesand advantages thereof, may be more easily understood by reference tothe drawings and the following description. The drawings are notintended to limit the scope of this presently disclosed subject matter,which is set forth with particularity in the claims as appended or assubsequently amended, but merely to clarify and exemplify the presentlydisclosed subject matter.

For a more complete understanding of the presently disclosed subjectmatter, reference is now made to the following drawings in which:

FIG. 1A is a schematic illustration of a step in a pre-operativeplanning method for designing a shoulder surgery guide where theanterior edge of a glenoid implant is aligned with an anterior edge of aglenoid bone, according to an embodiment of the disclosed subjectmatter;

FIG. 1B is a schematic illustration of a step in a pre-operativeplanning method for designing a shoulder surgery guide where theretroversion of a glenoid implant is adjusted, according to anembodiment of the disclosed subject matter;

FIG. 1C is a schematic illustration of a step in a pre-operativeplanning method for designing a shoulder surgery guide where theaugmentation of a glenoid implant is adjusted, according to anembodiment of the disclosed subject matter;

FIG. 1D is a schematic illustration of a step in a pre-operativeplanning method for designing a shoulder surgery guide where theinferior tilt of a glenoid implant is adjusted, according to anembodiment of the disclosed subject matter;

FIG. 1E is a schematic illustration of a step in a pre-operativeplanning method for designing a shoulder surgery guide where bonesupport for a glenoid implant is evaluated, according to an embodimentof the disclosed subject matter;

FIG. 1F is a schematic illustration of a step in a pre-operativeplanning method for designing a shoulder surgery guide where themedialization of a glenoid implant is adjusted by assessing thevolumetric amount of bone needed to be removed by reaming, according toan embodiment of the disclosed subject matter;

FIG. 1G is a schematic illustration of a step in a pre-operativeplanning method for designing a shoulder surgery guide where fixationsupport in the absence of central pegs that penetrate a vault mediallyis analyzed, according to an embodiment of the disclosed subject matter;

FIG. 1H is a schematic illustration of a step in a pre-operativeplanning method for designing a shoulder surgery guide where a jointline is analyzed by comparing an original joint line and a new jointline, according to an embodiment of the disclosed subject matter;

FIG. 1I is a schematic illustration of a step in a pre-operativeplanning method for designing a shoulder surgery guide where widths ofthe glenoid implant and the glenoid bone are measured and matched afterreaming and aligning inferior and superior axes of the glenoid implantand bone, according to an embodiment of the disclosed subject matter;

FIG. 2A is a schematic illustration of a step in a pre-operativeplanning method for designing a shoulder surgery guide where thediameter of a humeral head is determined, according to an embodiment ofthe disclosed subject matter;

FIG. 2B is a schematic illustration of a step in a pre-operativeplanning method for designing a shoulder surgery guide where the heightof a humeral head is determined, according to an embodiment of thedisclosed subject matter;

FIG. 2C is a schematic illustration of a step in a pre-operativeplanning method for designing a shoulder surgery guide where the size ofa humeral bone implant from Houndsfield units measured by computedtomography scan is determined, according to an embodiment of thedisclosed subject matter;

FIG. 2D is a schematic illustration of a step in a pre-operativeplanning method for designing a shoulder surgery guide where a best fitsize of implant from a range of sizes is determined, according to anembodiment of the disclosed subject matter;

FIG. 3 is a schematic illustration of a step in a pre-operative planningmethod for designing a shoulder surgery guide where vectors are comparedin three dimensions to measure the distance of relocation of humeraltuberosity compared to the scapula, according to an embodiment of thedisclosed subject matter;

FIG. 4 is a schematic illustration of a step in a pre-operative planningmethod for designing a shoulder surgery guide where range of motionanalysis is conducted, including virtually positioning implants throughextreme ranges of motion to measure impact locations and compensate fornecessary functional range of motion, according to an embodiment of thedisclosed subject matter;

FIG. 5 is a schematic illustration of a step in a pre-operative planningmethod for designing a shoulder surgery guide where soft tissue analysiscomprising determining key soft tissue insertion points is conducted,according to an embodiment of the disclosed subject matter;

FIG. 6 is a schematic illustration of a step in a pre-operative planningmethod for designing a shoulder surgery guide where penetration of thecortical wall anteriorily of the vault is assessed, according to anembodiment of the disclosed subject matter;

FIG. 7 is a schematic illustration of a step in a pre-operative planningmethod for designing a shoulder surgery guide where the width of thegreater tuberosity to medial head edge with an implant is compared tothe anatomic width, according to an embodiment of the disclosed subjectmatter;

FIGS. 8 and 9 are rear and front perspective views, respectively, of ashoulder surgery guide, according to an embodiment of the disclosedsubject matter;

FIG. 10 is a plan view a shoulder surgery guide, according to anembodiment of the disclosed subject matter; and

FIG. 11 is a perspective view of a shoulder surgery guide as used duringshoulder surgery on a glenoid surface of a scapula, according to anembodiment of the disclosed subject matter.

DETAILED DESCRIPTION

Patients requiring shoulder surgery may have one or more of the bones ofthe shoulder that are not only arthritic, but may also have had previousconditions that have caused bone to wear away. In such cases, there maynot be sufficient bone to adequately affix a prosthetic implant to thebone during a routine shoulder surgery. Indeed, the bones may have beenworn such that the orientation of a joint replacement cannot besatisfactorily determined to ensure a positive patient outcome.

The glenoid bone can be subject to increased wear due to bone arthriticconditions of the joint, and due to alterations of a normal soft tissueenvelope surrounding the joint. In such cases, the orientation of theface of the glenoid portion of the scapula bone may be altered so thatthe humeral bone is no longer appropriately apposed to the glenoidsurface. In the case where the glenoid is severely worn, there can betwo or more risks a surgeon must balance in an attempt to improveshoulder function and pain relief.

First, if the optimal orientation of the diseased but treated shoulderis not found and replicated with the prosthesis the patient mayexperience most operative complications related to subluxation ordislocation of the replaced shoulder joint. This can occur either due topassive inputs to the shoulder (e.g., leaning against it, or lying inbed), or due to active firing of surrounding soft tissue which is notable to be constrained by the replaced joint surfaces.

Additionally, the fixation of a replacement prosthesis, or implant, tothe native patient bone can be problematic. Frequently, in order tocounteract the risks associated with joint subluxation and dislocationdescribed above, it can be necessary for a surgeon to orient or positionthe replacement prosthesis or implant in a position better suited toresist imbalanced muscle forces. In such cases, separation forcesbetween the implant and the bone can increase, which in turn canincrease the potential for loosening of the joint prosthesis in thebone. Implant loosening can be related to accelerated implant wear, boneerosion, increased tissue inflammation, joint synovitis, and pain.

In patients that have undergone shoulder replacement surgery, range ofmotion and strength are dependent on shoulder kinematics, which are inturn dependent on a host of factors. Such factor can, for example,include for example implant size, implant position, the design ofimplant shape, the joint line and soft tissue tension. In some cases itcan be difficult to predict optimal implant size andposition/orientation using currently available guides and implants.Often times a surgeon finds that there are too many variables to manageat one time. Moreover, the size choices of implants can be limited tothe lowest practically functional groups to reduce economic burden tothe health care system. Current implant designs and methodologies areinadequate to address these challenges because they are of significantcost, require time to develop, include increased risk of implantfailure, and rely on human judgment of potential outcomespost-operatively.

There are many factors that can affect the optimal positioning ofshoulder implants during replacement surgery. For example, such factorscan include the patient size, relative bone wear, soft tissue strengthand condition, six degrees-of-freedom positioning of the glenoid and/orthe humeral prosthesis, selected implant size, preoperative patientactivity and strength levels, post operative treatment protocols, sizeand density of patient bone. Additional factors can include patientsmoking status, concomitant handicaps and/or patient problems. It can bequite difficult for a surgeon to understand and balance these factorssimultaneously. In addition, only a few of these factors are able to becontrolled by the surgeon. Finally, each factor does not necessarilyhave an equally weighted impact on patient outcome. Nevertheless, it isconsidered that the implant size, position, orientation and bonepreparation of the glenoid and the humerus can have a significant impacton the surgical outcomes.

A factor that further complicates, or makes more difficult, a surgeonstask of optimally placing a replacement component or implant tocounteract these risk is the fact that the condition of the scapula issuch that few landmarks exists for the surgeon the comprehend theimplant position within the bone. Thus, frequently a surgeon might findthat the implant position is not replicating as was envisioned duringthe surgical intervention.

Others have attempted to improve a surgeon's chance of providingsuccessful patient outcomes by providing operative techniques and tools.What is missing, however, is the ability to fully understand andincorporate multiple factors to optimize the implant selection andplacement. Specifically, in some embodiments, the success of the surgerycan be highly dependent on both the selection of the matching aprosthesis or prostheses (humeral and/or glenoid), as well aspositioning of this prosthesis, as well as the soft tissue status beforethe surgery. There have been no previous attempts at including thesefactors in surgical planning and implant design.

Disclosed herein are methods, systems and devices for pre-operativelyplanned shoulder surgery guides and implants. Methods, systems anddevices are provided for the replacement of the shoulder joint, such asthe glenohumeral joint, wherein the conditions of the humeral and softtissue envelop is taken into consideration. More specifically, what isconsidered is that the shape and position of the glenoid implant is notbased solely on what can be seen and measured on the scapula, but can bechosen, designed, planned and placed with incorporation of the sameinformation related to the humerus. After all, the shoulder is a twopart joint, i.e. glenoid and humeral head, wherein both parts work inconjunction with one another, and the factors that affect performance ofthe device can in some embodiments include factors from both sides ofthe joint.

Appropriate sizing of the prosthesis can be important to successfuloutcomes, knowing that oversized or “overstuffed” replacement shouldersare more likely to dislocate, loosen, be painful, and/or have decreasedrange of motion. Replaced joints where the orientation of the prosthesesis improper increases the likelihood of implant dislocation andloosening. Additionally, over-reaming, or too much bone removal, eitheron the glenoid, or the humerus, can be the cause of implant loosening,“under-stuffing” or inappropriate articular surface placement which canincrease pain and decrease range of motion.

Provided herein in some embodiments is a glenoid implant designed andmanufactured to specifically match the patient anatomy, includingoptimal humeral and/or glenoid implant size and shape, and taking intoaccount one or more of the following factors: assessment of the humeralimplant fit to the humeral bone; relative hardness of the patient bonepreoperatively; height and diameter of the humeral head placed on thehumeral stem; orientation, or “offset” of the humeral head; and optimalbone removal for preservation of soft tissue insertion and attachment.

Also provided herein are methods, systems and devices for creation of ashoulder surgery guide based on pre-operative planning which takes intoconsideration a plurality of factors and assessments. In someembodiments, the creation of a shoulder surgery guide based onpre-operative planning can comprise one or more of the following steps,the combination and order of which can vary: aligning an anterior edgeof a glenoid implant with an anterior edge of a glenoid bone; adjustinga retroversion of the glenoid implant; adjusting an augmentation of theglenoid implant; adjusting an inferior tilt of the glenoid implant;evaluating bone support for the glenoid implant, wherein an amount of arear surface of the glenoid implant that is supported by or touchingbone is assessed; adjusting the medialization of the glenoid implant byassessing the volumetric amount of bone needed to be removed by reaming,or the minimum total distance of reaming necessary, in order to optimizethe bone to implant interface; analyzing the fixation support in theabsence of central pegs that penetrate a vault medially; analyzing thejoint line, comprising comparing an original joint line and a new jointline, wherein the new joint line is substantially similar to theoriginal joint line; measuring and matching widths of the glenoidimplant and the glenoid bone after reaming and aligninginferior/superior axes of the glenoid implant and bone; assessing andadjusting as needed a thickness/height of the glenoid implant; assessingand adjusting as needed a depth of a glenoid fossa; assessing andadjusting as needed a thickness of a graft; determining a diameter of ahumeral head; determining a height of the humeral head; determining asize of humeral bone implant from Houndsfield units measured by animaging technique (e.g. computed tomography (CT) scan); and/ordetermining a best fit size of implant from a range of sizes, whereinthe range of sizes is selected from the group consisting of length ofstem, size of humeral stem, diameter of stem, size diameter of head,height of head, and offset of the center spherical head compared to thecenter of the face of the humeral stem.

In some embodiments, a pre-operative planning method for designing ashoulder surgery guide is provided for designing a guide for theglenoid. Such a method can be separate from a pre-operative planningmethod for the humerus, or can in some embodiments be done inconjunction with the planning for the humerus, or humeral side of thejoint. Such planning steps particular to the glenoid side of the jointcan comprise analysis steps such as those depicted in FIGS. 1A-1I.

For example, a pre-operative planning method for the glenoid cancomprise a step 101, as depicted in FIG. 1A, where the anterior edge 18of glenoid implant 20 can be aligned 30 with anterior edge 16 of glenoid12 of scapula bone 10 of a patient to be treated. In some embodiments,this step, as with other pre-operative analyses disclosed herein, can beaccomplished virtually based on images, e.g. CT images or X-ray images,taken from a subject or patient prior to surgery. By aligning anterioredge 18 of glenoid implant 20 with anterior edge 16 of glenoid 12, dataand information can be collected that informs the selection of a glenoidimplant and/or supports the creation of a shoulder surgery guide devicespecific to the patient or subject to be treated.

In some embodiments, a pre-operative planning method for the glenoid cancomprise a step 102, as depicted in FIG. 1B, where the retroversion 32of glenoid implant 20 is adjusted and/or measured. The retroversion isthe placement or degree of posterior rotation of glenoid implant 20 whenglenoid 12, including posterior wear 14 (see FIG. 1A), is reamed orotherwise resurfaced to accommodate glenoid implant 20. Such ameasurement of retroversion 32 of glenoid implant 20 can be incomparison to the retroversion of the native glenoid in a subject to betreated. In some embodiments, adjusting the retroversion comprisesadjusting the retroversion to be about 5 degrees (5°) to about 10degrees (10°), with a maximum of 10°. In some embodiments, this analysiscan be accomplished virtually based on images taken from a subject orpatient prior to surgery. By measuring and/or adjusting the retroversion32 of glenoid implant 20, data and information can be collected thatinforms the selection of a glenoid implant and/or supports the creationof a shoulder surgery guide device specific to the patient or subject tobe treated.

In some embodiments, a pre-operative planning method for the glenoid cancomprise a step 103, as depicted in FIG. 1C, where a determination canbe made as to the necessity of augmentation 34 to support glenoidimplant 20. In some embodiments, particularly where glenoid 12 includesposterior wear 14 (or wear at other locations of glenoid 12 not depictedin FIG. 1C), augmentation can be necessary and/or desirable to provideadequate support for the placement and/or attachment of implant 20. Sucha step or analysis can in some embodiments comprise adjusting, sizingand/or measuring augmentation 34 needed. In some embodiments, thisanalysis can be accomplished virtually based on images taken from asubject or patient prior to surgery. By assessing the need foraugmentation 34, and/or determining the type and/or size of augmentation34, data and information can be collected that informs the selection ofa glenoid implant and/or supports the creation of a shoulder surgeryguide device specific to the patient or subject to be treated.

In some embodiments, a pre-operative planning method for the glenoid cancomprise a step 104, as depicted in FIG. 1D, where the inferior tilt 36of glenoid implant 20 can be measured and/or assessed. Such ameasurement of inferior tilt 36 of glenoid implant 20 can be incomparison to the tilt of the native glenoid in a subject to be treated.In some embodiments, this analysis can be accomplished virtually basedon images taken from a subject or patient prior to surgery. By assessingthe inferior tilt 36 of glenoid implant 20, data and information can becollected that informs the selection of a glenoid implant and/orsupports the creation of a shoulder surgery guide device specific to thepatient or subject to be treated.

In some embodiments, a pre-operative planning method for the glenoid cancomprise a step 105, as depicted in FIG. 1E, where the bone support 38for glenoid implant 20 can be measured and/or assessed. Such anassessment can in some embodiments comprise characterizing and/orquantifying the amount or degree of bone support 38 for back side 22 ofimplant 20, taking into consideration posterior wear 14 (see, e.g.,FIGS. 1A or 1C; or wear at other locations of glenoid 12 not depicted).In some embodiments, this analysis can be accomplished virtually basedon images taken from a subject or patient prior to surgery. By assessingthe bone support 38, data and information can be collected that informsthe selection of a glenoid implant and/or supports the creation of ashoulder surgery guide device specific to the patient or subject to betreated.

In some embodiments, a pre-operative planning method for the glenoid cancomprise a step 106, as depicted in FIG. 1F, where medialization 42 ofglenoid implant 20 can be adjusted and/or characterized by assessing thevolumetric amount 40 of bone needed to be removed by reaming. In someembodiments, this analysis can be accomplished virtually based on imagestaken from a subject or patient prior to surgery. By assessing the bonesupport 38, data and information can be collected that informs theselection of a glenoid implant and/or supports the creation of ashoulder surgery guide device specific to the patient or subject to betreated.

In some embodiments, a pre-operative planning method for the glenoid cancomprise a step 107, as depicted in FIG. 1G, where fixation support inthe absence of a central peg 44 that penetrates a vault medially ofscapula 10 can be analyzed. In some embodiments, it is desirable toidentify a location on the glenoid for attachment of a prosthesis usinga peg or other fixation component without penetrating the anterior wallof the scapula. In some embodiments, this analysis can be accomplishedvirtually based on images taken from a subject or patient prior tosurgery. By assessing the fixation support, data and information can becollected that informs the selection of a glenoid implant and/orsupports the creation of a shoulder surgery guide device specific to thepatient or subject to be treated.

In some embodiments, a pre-operative planning method for the glenoid cancomprise a step 108, as depicted in FIG. 1H, where a joint line can beanalyzed by comparing an original joint line 46 with a new joint line 48as created when implant 20 is affixed to the glenoid surface of scapula10. The degree to which the joint line changes or shifts, and/or thechange in the angle, can be used in optimizing the implant 20 selectionand/or placement. In some embodiments, analyzing the joint line,including comparing the original joint line and the new joint line, cancomprise analyzing the humeral head lateralization. Humeral headlateralization can comprise the distance the humeral shaft is movedlaterally relative to the scapula after the implants are placed. In someembodiments, this analysis can be accomplished virtually based on imagestaken from a subject or patient prior to surgery. By assessing the jointline, data and information can be collected that informs the selectionof a glenoid implant and/or supports the creation of a shoulder surgeryguide device specific to the patient or subject to be treated.

In some embodiments, a pre-operative planning method for the glenoid cancomprise a step 109, as depicted in FIG. 1I, where the widths of theglenoid implant 50 a and the glenoid bone 50 b can be measured andmatched after reaming and aligning inferior 56 and superior 58 axes ofthe glenoid implant and bone. Particularly, in some embodiments, aglenoid implant 50 a height 52 a and width 54 a can be measured andaligned with a glenoid bone 50 b height 52 b and width 54 b alonginferior 56 and superior 58 axes. In some embodiments, this analysis canbe accomplished virtually based on images taken from a subject orpatient prior to surgery. By measuring the widths of the glenoid implant50 a and the glenoid bone 50 b, and aligning inferior 56 and superior 58axes of the glenoid implant and bone, data and information can becollected that informs the selection of a glenoid implant and/orsupports the creation of a shoulder surgery guide device specific to thepatient or subject to be treated.

Such planning steps particular to the glenoid side of the joint cancomprise analysis steps such as those depicted in FIGS. 1A-1I, and cancomprise all or some of the steps depicted in FIGS. 1A-1I, and in someaspects can be done in any order desired. Alternatively, in someembodiments analysis steps particular to fixation elements can beperformed first followed by analysis steps particular to jointarticulation.

In some embodiments, a pre-operative planning method for designing ashoulder surgery guide is provided for designed a guide for the humerus,or humeral bone. Such a method can be separate from a pre-operativeplanning method for the glenoid (discussed above and depicted in FIGS.1a -1I), or can in some embodiments be done in conjunction with theplanning for the glenoid, or glenoid side of the joint. Such planningsteps particular to the humerus side of the joint can comprise analysissteps such as those depicted in FIGS. 2A-2D.

For example, a pre-operative planning method for the humerus cancomprise a step 201, as depicted in FIG. 2A, where the diameter d ofhumeral head 60 of humerus 62 can be measured. In some embodiments, thisanalysis can be accomplished virtually based on images taken from asubject or patient prior to surgery. By measuring diameter d of humeralhead 60, data and information can be collected that informs theselection of a humeral head implant and/or supports the creation of ashoulder surgery guide device specific to the patient or subject to betreated.

In some embodiments, a pre-operative planning method for the humerus cancomprise a step 202, as depicted in FIG. 2B, where the height h ofhumeral head 60 of humerus 62 can be measured. In some embodiments, thisanalysis can be accomplished virtually based on images taken from asubject or patient prior to surgery. By measuring height h of humeralhead 60, data and information can be collected that informs theselection of a humeral head implant and/or supports the creation of ashoulder surgery guide device specific to the patient or subject to betreated.

In some embodiments, a pre-operative planning method for the humerus cancomprise a step 203, as depicted in FIG. 2C, where the size of a humeralbone implant stem portion 70 can be determined from Houndsfield units(the Hounsfield scale, named after Sir Godfrey Newbold Hounsfield, is aquantitative scale for describing radiodensity) measured by CT scan. Insome embodiments, this analysis can be accomplished virtually based onimages taken from a subject or patient prior to surgery. By measuringthe size of a humeral bone implant, data and information can becollected that informs the selection of a humeral head implant and/orsupports the creation of a shoulder surgery guide device specific to thepatient or subject to be treated.

In some embodiments, a pre-operative planning method for the humerus cancomprise a step 204, as depicted in FIG. 2D, where a best fit size ofhumeral implant 72 from a range of sizes can be determined. In someembodiments, the range of sizes can be selected from the groupconsisting of length of stem, size of humeral stem, diameter of stem,size diameter of head, height of head, and offset of the centerspherical head compared to the center of the face of the humeral stem.In some embodiments, this analysis can be accomplished virtually basedon images taken from a subject or patient prior to surgery. Bydetermining the most appropriate size of humeral implant 72, data andinformation can be collected that informs the selection of a humeralhead implant and/or supports the creation of a shoulder surgery guidedevice specific to the patient or subject to be treated.

Such planning steps particular to the humeral side of the joint cancomprise analysis steps such as those depicted in FIGS. 2A-2D, and cancomprise all or some of the steps depicted in FIGS. 2A-2D, and in someaspects can be done in any order desired. Alternatively, in someembodiments analysis steps particular to joint articulation can beperformed first followed by analysis steps particular to fixationelements.

In some embodiments, a pre-operative planning method for designing ashoulder surgery guide can comprise comparing vectors 80 in threedimensions to measure the distance of relocation of humeral tuberosity72 compared to the scapula 10, as depicted in analysis 205 in FIG. 3.For example, there are 3 rotator cuff tendons that attach to theproximal humerus in the area of the greater tuberosity and the scapula.Such attachment points are depicted as v and w, respectively, in FIG. 3.These tendons control much of the rotation of the humerus about thescapula as well as having a part in elevating the humerus. If the vectorresolved from these 3 tendons changes, kinematics and kinetics of theglenohumeral joint (joint comprising the glenoid and humerus) change.For example, changing the direction of vector 80 can change wearpatterns and range of motion (ROM) of the implanted device versus thenative joint. Additionally, in some embodiments, changing the magnitudeof vector 80 by lengthening or increasing it with a joint prosthesisthat is too large for the joint can result in decreased ROM, pain, andincreased wear of the prosthetic components. Finally, changing themagnitude of vector 80 by decreasing or shortening it with a jointprosthesis that is too small for the joint can result in an unstablejoint that may dislocate and can result in suboptimal mechanics forelevating the humerus. In some embodiments, this analysis can beaccomplished virtually based on images taken from a subject or patientprior to surgery. By comparing vector 80 in three dimensions to measurethe distance of relocation of humeral tuberosity 72 compared to thescapula 10, data and information can be collected that informs theselection of a humeral head implant, glenoid implant, and/or supportsthe creation of a shoulder surgery guide device specific to the patientor subject to be treated.

In some embodiments, a pre-operative planning method designing ashoulder surgery guide can comprise a step 206, as depicted in FIG. 4,where range of motion (ROM) analysis 82 can be conducted, includingvirtually positioning implants 20, 72 through extreme ranges of motionto measure impact locations and compensate for necessary functional ROM.In some embodiments, this analysis can be accomplished virtually basedon images taken from a subject or patient prior to surgery. By measuringthe ROM with respect to glenoid implants 20 and/or humeral implants 72,data and information can be collected that informs the selection ofglenoid implant, a humeral head implant and/or supports the creation ofa shoulder surgery guide device specific to the patient or subject to betreated.

In some embodiments, a pre-operative planning method designing ashoulder surgery guide can comprise a step 207, as depicted in FIG. 5,where soft tissue, e.g. muscle, analysis is conducted. In some aspects,soft tissue analysis can comprise determining and/or assessing softtissue insertion points (e.g., X, Y and Z) and analyzing impacts onand/or impacts from use of one or more implants (glenoid and/orhumeral). In some embodiments, four rotator cuff muscles and theirattachments points can be analyzed. For example, in some aspectsanalysis can comprise the subscapularis that attaches at an attachmentpoint Y near the lesser tuberosity and at an attachment point X near theanterior glenoid. In some aspects analysis can comprise thesupraspinatus that attaches at an attachment point Z near the anteriorgreater tuberosity and above the scapular spine (shoulder blade; notshown). In some aspects, soft tissue analysis can comprise theinfraspinatus that attaches at the greater tuberosity (posterior tosupraspinatus) and below the scapular spine (posterior). In someaspects, soft tissue analysis can comprise the teres minor that attachesposterior on the humerus and on the inferior scapular boder. In someembodiments, this analysis can be accomplished virtually based on imagestaken from a subject or patient prior to surgery. By analyzing the softtissue around the glenohumeral joint, data and information can becollected that informs the selection of a glenoid implant, a humeralhead implant and/or supports the creation of a shoulder surgery guidedevice specific to the patient or subject to be treated.

In some embodiments, the disclosed pre-operative planning methods canfurther comprise designing a shoulder surgery guide device based uponparameters collected from the planning methods and analyses. In someembodiments, a designed shoulder surgery guide can be produced, whereinthe produced surgery guide is configured in accordance with parameterscollected from the planning and analysis specific to the patient to betreated. In some aspects, a guide, and/or a prosthetic implant, can beproduced or made using a three dimensional (3D) printing device. In someembodiments, a shoulder surgery guide device produced as disclosedherein can comprise a polymeric or metallic material.

In some embodiments, the disclosed pre-operative planning methods canfurther comprise identifying a prosthetic shoulder implant, and/oridentifying a placement position for the prosthetic shoulder implant.The identification of a prosthetic shoulder implant and placementposition takes into consideration at least one of the factors selectedfrom the group consisting of adjustments in glenoid implant size,augmentation depth, augment position, positioning in six degrees offreedom, fixation type, fixation size, reaming depth, reaming diameter,reaming angle, and/or a combination thereof. The above method canfurther comprise a step of recommending implants and placementpositions, with recommended adjustments in humerus stem size, length,head diameter, head height, head offset and rotation (axial). Aprosthetic shoulder implant can in some embodiments comprise a glenoidimplant.

In some embodiments, the above methods of creating a shoulder surgeryguide based on pre-operative planning can further comprise one or moreoptimization steps. Such optimization steps can comprise theidentification of procedural risks based on measurements of one or moreof a plurality of factors. Such factors can in some embodiments comprisewhether the glenoid face coverage is maximized (e.g. about 0 to about 2mm), the overhang of the glenoid face is minimized (e.g. about 0 toabout 3 mm), and/or the bone removal on the glenoid face is minimized,such as for example less than about 2 mm of depth. Continuing, in someembodiments such optimization factors can comprise whether the glenoidretroversion is less than about 5 degrees to about 10 degrees, theseating of the glenoid implant is greater than about 80%, i.e. about 80%of the back side of the glenoid implant is supported by or touchingbone, whether there is minimized penetration of the glenoid corticalwall anteriorily (e.g. about 0 mm to about 3 mm), and/or the depth ofany glenoid implant augment feature is as minimal as possible. Stillyet, in some embodiments such optimization factors can comprise whetherthere is less than about 1 mm of difference between the anatomic jointline and the new joint line with implants, there is minimizedpenetration of the glenoid cortical wall anteriorily, and/or there ismaximized bone thickness behind the glenoid, preferably greater than 3mm. In some embodiments such optimization factors can comprise whetherthe orientation offset between the native glenoid and implantsuperior/inferior axis is minimized, preferably less than 5 degrees, thesuperior or inferior tilt versus native glenoid is minimized, preferablyless than 5 degrees, there is less than about 5% to about 10% change insoft tissue length at extreme ranges of motion, there is maximizedfiling of the humeral metaphysis, in some embodiments greater than about90% of metaphyseal bone filled based on and identification ofmetaphyseal bone by use of Houndsfield units, there is an absence of ahumeral head overhang compared to the cut, or prepared surface of thehumeral bone, there is minimal difference in humeral head diameterbetween anatomic and implant, in some embodiments less than about 3 mm,there is minimal difference in humeral head height between anatomic andimplant, in some embodiments less than about 1 mm, and/or there isgreater tuberosity to medial head edge comparison to anatomic, in someembodiments less than about 2 mm. In some embodiments, such proceduralrisks (any and/or all from the above list) can be determined virtuallybased on images taken from a subject prior to surgery.

With respect to the above optimization steps that comprise theidentification of procedural risks, in some embodiments the penetrationof the cortical wall anteriorily of the vault can be assessed, asdepicted in FIG. 6. FIG. 6 depicts step 208 of assessing the penetrationof the cortical wall anteriorily of the vault 88 by a support structure84 of glenoid implant 20. In some embodiments, an additional oralternate support structure 86 can be used to affix implant 20 toglenoid 12.

Also with respect to the above optimization steps that comprise theidentification of procedural risks, in some embodiments the width of thegreater tuberosity to medial head edge with an implant can be comparedto the anatomic width. For example, in FIG. 7 the width 90 of thegreater tuberosity to medial head edge with an implant 72 can becompared to the width of the anatomical humeral head.

In some aspects, the planning methods and analysis steps disclosedherein can be done pre-operatively. That is, they can be done prior tosurgery in a virtual or software-based environment. Such virtualsimulations can in some embodiments be based on images or scans takenfrom a subject prior to surgery. Currently available and future imagingtechniques, e.g. computed tomography (CT), x-ray imaging, positronemission tomography (PET), ultrasound, etc., can be used to captureimages and data to be used in simulation-based analysis and planning toidentify suitable prosthetic implants and/or design surgery guides. Byusing images captured from a subject or patient to be treated, theanalysis and results can be specific to the subject or patient and cantake into consideration the particularities of that subject's condition.

The subject matter described herein may be implemented in software incombination with hardware and/or firmware. For example, the subjectmatter described herein may be implemented in software executed by aprocessor. In one exemplary implementation, the subject matter describedherein may be implemented using a computer readable medium having storedthereon computer executable instructions that when executed by theprocessor of a computer control the computer to perform steps. Exemplarycomputer readable media suitable for implementing the subject matterdescribed herein include non-transitory devices, such as disk memorydevices, chip memory devices, programmable logic devices, andapplication specific integrated circuits. In addition, a computerreadable medium that implements the subject matter described herein maybe located on a single device or computing platform or may bedistributed across multiple devices or computing platforms.

As such, in some embodiments the disclosed pre-operative planningmethods can further comprise providing a computer readable medium havingstored thereon executable instructions that when executed by theprocessor of a computer control the computer to perform one or more ofthe planning method and/or analysis steps. For example, in someembodiments computer readable medium can have stored thereon executableinstructions that when executed by the processor of a computer cancontrol the computer to generate a virtual 3D model of a glenoid guidedevice reflecting one or more optimized parameters determined duringpre-operative planning. Additionally, in some aspects, computer readablemedium can have stored thereon executable instructions that whenexecuted by the processor of a computer control the computer to controla 3D printing device in communication with the computer, whereby the 3Dprinting device can print a glenoid guide device or humeral guide devicefor use in shoulder replacement surgery in a patient for whichpre-operative planning method steps were conducted.

Further, in some aspects of the disclosed methods, systems and devices,a computer readable medium can be provided having stored thereonexecutable instructions that when executed by a processor of a computercan control the computer to generate a virtual 3D model of a glenoidimplant device reflecting one or more optimized parameters determinedduring pre-operative planning. Thus, in some embodiments a computerreadable medium is provided, wherein the computer readable medium hasstored thereon executable instructions that when executed by theprocessor of a computer control the computer to perform one or more ofthe planning method and/or analysis steps as disclosed herein.

It should be noted that the computers, computing devices, hardwareand/or functionality described herein may constitute a special purposetest device. Further, computers, computing devices, hardware and/orfunctionality described herein can improve the technological field ofpre-operative planning for shoulder surgery and can improve generationof virtual modeling systems.

The subject matter described herein for generating 3D models of glenoidand/or humeral implant devices, and/or for modeling and virtuallysimulating pre-operative shoulder surgery analysis improves thelikelihood of a positive outcome from shoulder surgery. It should alsobe noted that a computing platform, computer, computing device, and/orhardware that implements the subject matter described herein maycomprise a special purpose computing device usable to generate 3D modelsof glenoid and/or humeral implant devices, and/or for modeling andvirtually simulating pre-operative shoulder surgery analysis.

As used herein, the term “node” refers to a physical computing platformincluding one or more processors and memory.

As used herein, the terms “function” or “module” refer to hardware,firmware, or software in combination with hardware and/or firmware forimplementing features described herein.

In some embodiments a computer readable medium is provided, havingstored thereon executable instructions that when executed by theprocessor of a computer control the computer to perform steps comprisinggenerating a virtual three dimensional model of a glenoid and/or humeralguide reflecting one or more optimized parameters determined duringpre-operative planning based on the above method steps. In someembodiments, a computer readable medium is provided, having storedthereon executable instructions that when executed by the processor of acomputer control a 3D printing device in communication with thecomputer, whereby the 3D printing device prints a glenoid and/or humeralguide for use in shoulder replacement surgery in a patient for which theoptimization analysis was conducted.

Based on the pre-operative planning steps and analyses disclosed herein,in some embodiments shoulder surgery guides or guide devices can bedesigned, simulated and in some instances produced for use in shoulderreplacement surgery. Such a surgery guide device is depicted in FIGS.8-11. FIGS. 8 and 9 are rear and front perspective views, respectively,of a shoulder surgery guide, while FIG. 10 is a plan view of a shouldersurgery guide. As depicted in FIGS. 8-10, shoulder surgery guide 300 canin some embodiments comprise a plurality of peripheral guide structures302 configured to align with the edge or rim of the glenoid face. InFIGS. 9-11 four peripheral guide structures 302, namely 302 a, 302 b,302 c, and 302 d, are shown, but any number of peripheral guidestructures 302, including for example 2, 3, 4, 5, 6, 7, 8, 9 or 10,could be used so long as there are a sufficient number to align andstabilize guide 300 on a glenoid face (see FIG. 11 for a depiction ofthe guide in use). In some embodiments, peripheral guide structures 302a, 302 b, 302 c, and 302 d can each comprise a corresponding indentationor cupped surface 310 a, 310 b, 310 c, and 310 d that can be configuredto wrap over the edge of the rim of the glenoid. Cupped surface 310 a,310 b, 310 c, and 310 d can secure and stabilize guide 300 at thedesired and predetermined (based on the pre-operative analysis and guidedesign) location on the glenoid. In some embodiments, some peripheralguide structures may not include a cupped surface, or may include adifferent shaped structure, as needed to accommodate and align with agiven point along the edge of a glenoid. Each peripheral guide structure302, and corresponding cupped surface 310, can be predetermined andconfigured based on individual datum points collected during apre-operative analysis and guide design, as disclosed herein.

Peripheral guide structures 302 a, 302 b, 302 c, and 302 d generallyextend radially from a hub structure 304, and can be positioned andsecured to hub structure 304 by radial arms 308 a, 308 b, 308 c, and 308d. Of course, the number of radial arms 308 will be dictated by, andcorrespond to, the number of peripheral guide structures 302. The lengthof radial arms 308 can be determined and configured based on individualdatum points collected during a pre-operative analysis and guide design,as disclosed herein, such that each of the peripheral guide structures302 align with the rim of the glenoid at the desired location.

Hub structure 304 can comprise a central port 306 comprising acylindrical opening extending through the entire length (see front viewFIG. 8, rear view FIG. 9, and plan view FIG. 10) of hub structure 304and providing an opening through which a pin, drill or boing device canbe guided to create an opening, i.e. drill a hole, and/or place a guidepin in the glenoid face. With peripheral guide structures 302 a, 302 b,302 c, and 302 d aligning with the rim or edge of the glenoid, hubstructure 304, by virtue of its attachment to each of peripheral guidestructures 302 a, 302 b, 302 c, and 302 d, can be aligned at thepredetermined and desired location on the face of a glenoid. Thelocation of hub structure 304, and particularly central port 306, can bepredetermined and configured based on pre-operative analysis such thatcentral port 306 provides a steady and secure guide to the location onthe glenoid where a prosthesis or implant is to be attached.

FIG. 11 depicts shoulder surgery guide 300 in use, or aligned with theface of glenoid 12 on scapula 10. Cupped surface 310 a, 310 b, 310 c,and 310 d wrap over the edge of the rim of the glenoid 12 such thatguide 300 is aligned with and stabilized over glenoid 12. With guide 300in place on glenoid 12, a pin, drill or boing device can be insertedinto central port 306, which can guide the pin, drill or boing device tothe precise location on glenoid 12 where a predetermined attachmentpoint is located based on pre-operative analytics.

In some embodiments, a hybrid patient specific implant can be provided,in some embodiments a humeral implant, wherein the hybrid implant cancomprise a fixation component and an articular component. The hybridpatient specific implant can comprise a standardized range of fixationcomponents for securing the implant to the humerus. Such fixationcomponent can comprise a stem comprising varying sizes, materials,coatings and surface treatments.

In some embodiments, an intermediate holder can be provided for securingthe articular component to the fixation component. Such intermediateholder can vary in size, can comprise standardized materials andcoatings, and can comprise a standardized connection between thefixation component, e.g. stem, and holder. Such standardized connectioncan comprise threads, interlocking components, morse taper connections,snap fit connections (whether using snap rings or not), and the like.

In some aspects, the customized patient specific articular component cancomprise a desired articular shape and/or position based on the methodsof analysis and optimization disclosed herein. By way of example and notlimitation, the shape and position of the articular component can becentered or offset, and can have varying degrees of depth.

In some aspects, the articular component can comprise a desired range ofmotion blockage. Range of motion tests with virtual pre-operativeplanning as discussed herein can reveal potential impingement of humeralpolyethylene on scapula bone, or humeral tuberosities on acromion. Insome aspects, an analysis comparing predicted range of motion based onnecessary activities of daily living can be conducted. In someembodiments, a further step can include resolving any conflicts betweenimpingement and activities of daily living needs. Taking these factorsinto consideration, the articular component shape and placement can thenbe optimized.

Additionally, in some embodiments, the articular component shape can beadjusted. Such variations, based in some aspects on pre-operativeplanning as discussed herein, can comprise variations in radiallocation, depth/magnitude and/or angle.

In some embodiments, methods of treating a patient, and/or surgicalmethods, are provided wherein one or more of the disclosed methods ofanalysis and optimization are performed on a patient in need of shoulderor other joint surgery. In some embodiments, methods of treating apatient are provided wherein a disclosed method of analysis andoptimization is performed, an optimized guide is designed and created,and one or more glenoid and/or humeral implants are designed, created,and/or selected. In some embodiments, a method of treating a patient cancomprise utilizing the pre-operative planning to design and optimize aguide and one or more glenoid and/or humeral implants, and the use ofthe guide to surgically implant the one or more glenoid and/or humeralprosthetic devices.

In some embodiments, a kit is provided wherein the kit can comprise aset of instructions for performing the disclosed pre-operative planningmethods and analyses. Such a kit can further comprise one or moreglenoid and/or humeral prosthetic devices, wherein the devices can becustomizable or modular in design such that the prosthetic device can beoptimized for the patient based on the pre-operative planning analysis.In some embodiments, a kit can further comprise a guide for placing aprosthetic device during shoulder surgery, wherein the guide can beoptimized for the patient based on the pre-operative planning analysis.In some embodiments, a kit can further comprise a 3-D printing devicefor producing a guide and/or one or more glenoid and/or humeralprosthetic devices. In some embodiments, a kit can further comprise acomputer-readable medium (software) for use in conducting thepre-operative planning, and designing a guide, glenoid implant and/orhumeral implant based on input parameters gathered during the disclosedmethods of analysis.

In some embodiments a patient can comprise a mammalian subject. In someembodiments, the patient can be a human subject, including an adult,adolescent or child.

While the following terms are believed to be well understood by one ofordinary skill in the art, the following definitions are set forth tofacilitate explanation of the presently disclosed subject matter.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood to one of ordinary skill inthe art to which the presently disclosed subject matter belongs.Although any methods, devices, and materials similar or equivalent tothose described herein can be used in the practice or testing of thepresently disclosed subject matter, representative methods, devices, andmaterials are now described.

Following long-standing patent law convention, the terms “a” and “an”mean “one or more” when used in this application, including the claims.

Unless otherwise indicated, all numbers expressing quantities ofingredients, reaction conditions, and so forth used in the specificationand claims are to be understood as being modified in all instances bythe term “about”. Accordingly, unless indicated to the contrary, thenumerical parameters set forth in this specification and attached claimsare approximations that can vary depending upon the desired propertiessought to be obtained by the presently disclosed subject matter.

As used herein, the term “about,” when referring to a value or to anamount of mass, weight, time, volume, concentration or percentage ismeant to encompass variations of in some embodiments ±20%, in someembodiments ±10%, in some embodiments ±5%, in some embodiments ±1%, insome embodiments ±0.5%, and in some embodiments ±0.1% from the specifiedamount, as such variations are appropriate to perform the disclosedmethod.

As used herein, the term “and/or” when used in the context of a listingof entities, refers to the entities being present singly or incombination. Thus, for example, the phrase “A, B, C, and/or D” includesA, B, C, and D individually, but also includes any and all combinationsand subcombinations of A, B, C, and D.

The term “comprising”, which is synonymous with “including,”“containing,” or “characterized by” is inclusive or open-ended and doesnot exclude additional, unrecited elements or method steps. “Comprising”is a term of art used in claim language which means that the namedelements are present, but other elements can be added and still form aconstruct or method within the scope of the claim.

As used herein, the phrase “consisting of” excludes any element, step,or ingredient not specified in the claim. When the phrase “consists of”appears in a clause of the body of a claim, rather than immediatelyfollowing the preamble, it limits only the element set forth in thatclause; other elements are not excluded from the claim as a whole.

As used herein, the phrase “consisting essentially of” limits the scopeof a claim to the specified materials or steps, plus those that do notmaterially affect the basic and novel characteristic(s) of the claimedsubject matter.

With respect to the terms “comprising”, “consisting of”, and “consistingessentially of”, where one of these three terms is used herein, thepresently disclosed and claimed subject matter can include the use ofeither of the other two terms.

As used herein, “significance” or “significant” relates to a statisticalanalysis of the probability that there is a non-random associationbetween two or more entities. To determine whether or not a relationshipis “significant” or has “significance”, statistical manipulations of thedata can be performed to calculate a probability, expressed as a “pvalue”. Those p values that fall below a user-defined cutoff point areregarded as significant. In some embodiments, a p value less than orequal to 0.05, in some embodiments less than 0.01, in some embodimentsless than 0.005, and in some embodiments less than 0.001, are regardedas significant. Accordingly, a p value greater than or equal to 0.05 isconsidered not significant.

It will be understood that various details of the presently disclosedsubject matter may be changed without departing from the scope of thepresently disclosed subject matter. Furthermore, the foregoingdescription is for the purpose of illustration only, and not for thepurpose of limitation.

What is claimed is:
 1. A method comprising: generating a glenoid bonepre-operative image of a subject for shoulder surgery; performing avirtual pre-operative planning process to design a surgery guide andselect at least one implant, wherein the pre-operative planning processgenerates a plurality of parameters by: aligning an anterior edge of avirtual glenoid implant with an anterior edge of the glenoid bonepre-operative image; adjusting a retroversion of the virtual glenoidimplant; adjusting an augmentation of the virtual glenoid implant;adjusting an inferior tilt of the virtual glenoid implant; evaluatingbone support for the virtual glenoid implant, wherein an amount of arear surface of the virtual glenoid implant that is supported by ortouching bone of the glenoid bone pre-operative image is assessed;adjusting a medialization of the virtual glenoid implant by assessingthe volumetric amount of bone of the glenoid bone pre-operativeimage-needed to be removed by reaming, or the minimum total distance ofreaming necessary, in order to optimize a bone to implant interface;analyzing fixation support of the virtual glenoid implant in the absenceof central pegs that penetrate a vault medially; analyzing an originaljoint line and a new joint line created by affixing the virtual glenoidimplant to the glenoid bone preoperative image, wherein analyzing theoriginal joint line and the new joint line comprises humeral headlateralization to measure a distance a humeral shaft is moved laterallyrelative to a scapula in the glenoid bone preoperative image; measuringand matching widths of the virtual glenoid implant and the glenoid bonepre-operative image after reaming and aligning inferior and superioraxes of the virtual glenoid implant and bone of the glenoid bonepre-operative image; assessing and adjusting as needed athickness/height of the virtual glenoid implant; assessing and adjustingas needed a depth of a glenoid fossa of the glenoid bone pre-operativeimage; assessing and adjusting as needed a thickness of a virtual graft;conducting a virtual range of motion analysis to identify impactlocations between the virtual glenoid implant and bone of the glenoidbone pre-operative image; based on the virtual range of motion analysis,assessing and adjusting as needed alignment and positioning of thevirtual glenoid implant relative to the glenoid bone pre-operativeimage; performing soft tissue analysis to determine soft tissueinsertion points and analyze impacts from the use of one or moreimplants; and manufacturing the surgery guide based on the plurality ofparameters collected from the pre-operative planning process, whereinthe surgical guide is configured to prepare a shoulder joint forinstallation of the at least one implant selected by the virtualpre-operative planning process.
 2. The method of claim 1, whereinadjusting the retroversion comprises adjusting the retroversion to beabout 5 degrees (5°) to about 10 degrees (10°), with a maximum of 10°.3. The method of claim 1, wherein manufacturing the surgery guidecomprises using a three dimensional printing device.
 4. The method ofclaim 1, wherein the surgery guide comprises a polymeric or metallicmaterial.
 5. The method of claim 1, wherein the at least one implantcomprises a physical prosthetic shoulder implant, and wherein thepre-operative planning process includes identifying a physical placementposition for the physical prosthetic shoulder implant.
 6. The method ofclaim 1, further comprising providing a non-transitory computer readablemedium having stored thereon executable instructions that when executedby the processor of a computer control the computer to perform thepre-operative planning process.
 7. The method of claim 6, wherein thenon-transitory computer readable medium having stored thereon executableinstructions that when executed by the processor of the computer controlthe computer to generate a three dimensional (3D) model of the surgeryguide reflecting one or more optimized parameters determined duringpre-operative planning.
 8. The method of claim 6, wherein thenon-transitory computer readable medium having stored thereon executableinstructions that when executed by the processor of the computer controlthe computer to control a 3D printing device in communication with thecomputer, whereby the 3D printing device prints the surgery guide foruse in shoulder replacement surgery in the subject for shoulder surgery.9. The method of claim 6, wherein the non-transitory computer readablemedium having stored thereon executable instructions that when executedby the processor of the computer control the computer to generate avirtual 3D model of an implant reflecting one or more optimizedparameters determined during pre-operative planning.